Public recall detail

Single Use Distal Cover and EVIS EXERA III Duodenovideoscope

2024-01-10

medium
Recall Safety notice
Quick summary

Quick summary: Single Use Distal Cover and EVIS EXERA III Duodenovideoscope. Date: 2024-01-10.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Single Use Distal Cover and EVIS EXERA III Duodenovideoscope. Date: 2024-01-10.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandOLYMPUS MEDICAL SYSTEMS CORP.
ProductSingle Use Distal Cover and EVIS EXERA III Duodenovideoscope
IssueMedical devices - Performance
Recall classType II
IdentificationRA-74893

Affected products

ProductSingle Use Distal Cover
LotAll lots.
ModelMAJ-2315
Serial numberAll lots.
DescriptionSingle Use Distal Cover
ProductEVIS EXERA III Duodenovideoscope
LotAll lots.
ModelTJF-Q190V
Serial numberAll lots.
DescriptionEVIS EXERA III Duodenovideoscope

Issue

The Single Use Distal Cover has been designed to be attached to Olympus duodenovideoscope to cover the distal end of the insertion tube and around the forceps elevator. The duodenovideoscope TJF-Q190V is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, endotherapy accessories and other ancillary equipment for endoscopy and endoscopic surgery. Olympus has become aware that the single use distal cover MAJ-2315 may unexpectedly detach from the duodenoscope during use. Recall Start Date: December 27, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Gastroenterology and urology Health products - Medical devices - Orthopaedics
CompaniesOlympus Medical Systems Corp. 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74893
Background{}
CompaniesOlympus Medical Systems Corp. 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507
AudiencesHealthcare
Source updated2024-01-10

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